ISO 14801

Fatigue testing of single post endosseous per ISO 14801 is most useful for comparing different dental implant designs and sizes. The standard simulates the functional loading of the dental implant body (prosthesis) and its mating components under ‘worst case’ conditions. However, it should not be used to predict in-vivo performance of the implant or prosthesis.

 

Both straight and angled implant design is addressed in ISO 14801 and provides testing parameters in either ambient air or physiologically relevant conditions (usually a 37C/buffered saline bath). Typically, the sample is angled at 30 degrees and a test frequency of 15Hz. Loading is in the range of several hundred Newtons. The implant is often tested in its finished device state. For multi-part dental implants, testing is performed on the device as assembled according to its intended use and mounted/used per manufacturers recommended procedures.

 

A special fixture designed to hold and support the implant body is required. This fixture base provides for angular adjustment while a slide mechanism to allow positioning of the implant and placed axially concentric with the loading component of the test system. The upper loading component must freely allow for the lateral motion the implant would experience during testing. The implant can be tested in the most practical or convenient manner as defined by the standard. Screw-in implant bodies can be either “potted” or screwed-in directly to the holder. Per ISO 14801 loading schematic, the loading force shall be applied so that no lateral constraint occurs, and the loading center is well-defined so that the moment arm (y) is easily measured/calculated.

 

Solutions for ISO 14801 typically include these components:

 

The MTS Acumen® Electrodynamic Test Systems are an ideal solution for testing per ISO 14801. It’s capable of applying the prescribed load with an error not exceeding +-5% of maximum load. When configured with the dental fatigue test fixture, testing is a plug-n-play exercise. The MTS Acumen systems are ideal for ultra clean laboratories. Designed with proven, highly efficient electric linear motors, these systems provide clean, quiet and cost-effective operation. Electrodynamic actuation consumes less energy than other technologies and can be put into service quickly without additional infrastructure such as hydraulic power units, high pressure hoses or water cooling/chiller systems.

 

The MTS Acumen systems can be set up in any location with a 110/220v electrical outlet. Additionally, with higher forces (to 3000N) and higher frequencies (to 100Hz) Stress/Strain (S/N curves) are easily and quickly generated as part of the fatigue protocol required to meet device submission guidelines to MTS Acumen regulatory governing entities.

 

Dental fixture with linear positioning to provide 30 degrees (as required) of angular adjustment. Interchangeable specimen holder for either a potting material (modulus of elasticity > 3 GPa) or screw-in mounting of implant body.